HPTN 058

Study Purpose

To determine the efficacy of a drug treatment intervention involving administration of a buprenorphine/ naloxone (BUP/NX) combination for 52 weeks plus drug and risk-reduction counseling (hereafter referred to as "long-term medication assisted treatment") compared with short-term medication assisted treatment with BUP/NX plus drug and risk-reduction counseling (hereafter referred to as "short-term medication assisted treatment") for the prevention of HIV transmission and death among opiate dependent injectors by reducing drug use and associated risk behavior.

Study Design

This is a Phase III, multi-site, two-arm, open-label, randomized, controlled trial. An initial safety and feasibility phase will include the first 50 study participants at each site.

Study Population

Participans will be HIV-uninfected, opiate dependent injection drug users who meet the eligibility criteria will be recruited from the community.

Study Size

A total of 1500 opiate dependent injectors will be enrolled.

Study Duration

Approximately 5 years; each participant followed for 2-3 years.

Treatment Regime

Long-term Medication Assisted Treatment Arm: Sublingual BUP/NX daily up to 21 days (until dose stabilization) and then three times per week for 52 weeks; plus weekly individual drug- and risk-reduction counseling for twelve weeks, followed thereafter by monthly counseling sessions every four weeks through week 52.
Vs.
Short-term Medication Assisted Treatment Arm: Sublingual BUP/NX for 18 days maximum with a second short-term medication assisted treatment possible at week 26; plus weekly individual drug- and risk-reduction counseling for twelve weeks, followed thereafter by monthly counseling sessions every four weeks through week 52.

Primary Objectives

To determine whether 52 weeks of long-term medication assisted treatment with BUP/NX and counseling treatment in opiate addicted participants will achieve a long term (104 weeks) reduction in cumulative HIV incidence and death compared to short-term medication assisted treatment and counseling.

Secondary Objectives

Other Objectives